EMDN C02: Arrhythmology Devices

Registered classes, as of 8 Sep 2026. For each code with at least 20 registrations under a legislation, the chip shows how devices registered in EUDAMED under that code are classed, counted once per primary UDI-DI and kept separate for each legislation. It is not a determination. The class of a device comes from the MDR and IVDR classification rules for its intended purpose. MDD and IVDD classes are the directive classification and can differ from the class the same device would have under MDR or IVDR.

• C02Arrhythmology Devices
  • C0201Cardiac Electrophysiology and Mapping Devices
    • C020101Arrhythmology Bipolar Diagnostic Cathetersterminal
    • C020102Arrhythmology Tripolar Diagnostic Cathetersterminal
    • C020103Arrhythmology Tetrapolar Diagnostic Cathetersterminal
    • C020104Arrhythmology Multipolar Diagnostic Catheters
      • C02010401Arrhythmology Multipolar Diagnostic Catheters, ConventionalMDD 100.0% Class III · n=28terminal

        Registered in EUDAMED under MDD with this code: 28 of 28 devices carry Class III on their registration (as of 8 Sep 2026).

        • 28 Class III (100.0%)

        Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

      • C02010402Arrhythmology Multipolar Diagnostic Catheters, Basket Typeterminal
      • C02010403Arrhythmology Multipolar Diagnostic Catheters, Adjustableterminal
      • C02010499Arrhythmology Multipolar Diagnostic Catheters – Otherterminal
    • C020105Non-Conventional Mapping (Contact and Non-Contact) Three-Dimensional Diagnostic Cathetersterminal
    • C020180Cardiac Electrophysiology and Mapping Devices - AccessoriesMDR 100.0% Class I · n=56terminal

      Registered in EUDAMED under MDR with this code: 56 of 56 devices carry Class I on their registration (as of 8 Sep 2026).

      • 56 Class I (100.0%)

      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

    • C020199Cardiac Electrophysiology and Mapping Devices - OtherMDR 3 classes · n=53MDD 2 classes · n=30terminal

      Registered in EUDAMED under MDR with this code, the 53 devices are split across classes (as of 8 Sep 2026).

      • 42 Class I (79.2%)
      • 6 Class IIa (11.3%)
      • 5 Class IIb (9.4%)

      Registered in EUDAMED under MDD with this code, the 30 devices are split across classes (as of 8 Sep 2026).

      • 28 Class III (93.3%)
      • 2 Class I (6.6%)

      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

  • C0202Cardiac Temporary Stimulation Devices (with or without Active Substances)
    • C020201Temporary Endocardial Leadsterminal
    • C020202Epicardial Leads (Monopolar and Bipolar)MDR 100.0% Class III · n=214terminal

      Registered in EUDAMED under MDR with this code: 214 of 214 devices carry Class III on their registration (as of 8 Sep 2026).

      • 214 Class III (100.0%)

      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

    • C020203Transoesophageal Recording and Stimulation LeadsMDR 100.0% Class IIa · n=25terminal

      Registered in EUDAMED under MDR with this code: 25 of 25 devices carry Class IIa on their registration (as of 8 Sep 2026).

      • 25 Class IIa (100.0%)

      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

    • C020280Temporary Cardiac Electrical Stimulation Devices - Accessoriesterminal
    • C020299Cardiac Temporary Stimulation Devices (with or without Active Substances) - OtherMDR 3 classes · n=65MDD 100.0% Class IIb · n=37terminal

      Registered in EUDAMED under MDR with this code, the 65 devices are split across classes (as of 8 Sep 2026).

      • 49 Class III (75.3%)
      • 15 Class I (23.0%)
      • 1 Class IIb (1.5%)

      Registered in EUDAMED under MDD with this code: 37 of 37 devices carry Class IIb on their registration (as of 8 Sep 2026).

      • 37 Class IIb (100.0%)

      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

  • C0203Cardiac Tissue Ablation Devices
    • C020301Arrhythmogenic Foci Radiofrequency Ablation CathetersMDD 100.0% Class III · n=61terminal

      Registered in EUDAMED under MDD with this code: 61 of 61 devices carry Class III on their registration (as of 8 Sep 2026).

      • 61 Class III (100.0%)

      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

    • C020302Arrhythmogenic Foci Cryoenergy Ablation Cathetersterminal
    • C020304Arrhythmogenic Foci Pulsed Field Ablation Cathetersterminal
    • C020305Arrhythmogenic Foci Laser Ablation Cathetersterminal
    • C020380Ablation of Arrhythmogenic Focus Devices - AccessoriesMDD 100.0% Class I · n=23terminal

      Registered in EUDAMED under MDD with this code: 23 of 23 devices carry Class I on their registration (as of 8 Sep 2026).

      • 23 Class I (100.0%)

      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

    • C020399Cardiac Tissue Ablation Devices - OtherMDR 3 classes · n=146terminal

      Registered in EUDAMED under MDR with this code, the 146 devices are split across classes (as of 8 Sep 2026).

      • 115 Class I (78.7%)
      • 25 Class IIb (17.1%)
      • 6 Class III (4.1%)

      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

  • C0204External Cardioversion and Defibrillation Devices
    • C020401External Cardioversion Defibrillator Electrode PadsMDR 2 classes · n=793terminal

      Registered in EUDAMED under MDR with this code, the 793 devices are split across classes (as of 8 Sep 2026).

      • 562 Class IIb (70.8%)
      • 231 Class I (29.1%)

      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

    • C020402Temporary Cardioversion Leads
      • C02040201Temporary Endocavitary Cardioversion Leadsterminal
      • C02040202Temporary Transoesophageal Cardioversion Leadsterminal
      • C02040299Temporary Cardioversion Leads - Otherterminal
    • C020480Cardioversion and External Defibrillation Devices - AccessoriesMDD 100.0% Class I · n=90terminal

      Registered in EUDAMED under MDD with this code: 90 of 90 devices carry Class I on their registration (as of 8 Sep 2026).

      • 90 Class I (100.0%)

      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

    • C020499External Cardioversion and Defibrillation Devices - OtherMDD 100.0% Class IIb · n=24terminal

      Registered in EUDAMED under MDD with this code: 24 of 24 devices carry Class IIb on their registration (as of 8 Sep 2026).

      • 24 Class IIb (100.0%)

      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination. MDD and IVDD classes are the directive classification and can differ under MDR or IVDR.

  • C0205Cardiac Diagnostic Devices
    • C020501ECG ElectrodesMDR 100.0% Class I · n=1,907terminal

      Registered in EUDAMED under MDR with this code: 1,907 of 1,907 devices carry Class I on their registration (as of 8 Sep 2026).

      • 1,907 Class I (100.0%)

      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

    • C020599Cardiac Diagnostic Devices - OtherMDR 4 classes · n=435terminal

      Registered in EUDAMED under MDR with this code, the 435 devices are split across classes (as of 8 Sep 2026).

      • 367 Class I (84.3%)
      • 56 Class III (12.8%)
      • 10 Class IIa (2.2%)
      • 2 Class IIb (0.4%)

      Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

  • C0280Arrythmology Devices - Accessories not Included in Other ClassesMDR 99.3% Class I · n=291terminal

    Registered in EUDAMED under MDR with this code: 289 of 291 devices carry Class I on their registration (as of 8 Sep 2026).

    • 289 Class I (99.3%)
    • 2 Class IIa (0.6%)

    Counted once per primary UDI-DI, using the class on the registration. The class of a device comes from the MDR and IVDR classification rules for its intended purpose, so a code is evidence of how others registered, not a determination.

  • C0299Arrhythmology Devices - Otherterminal